Headset

GUDID 04719878713078

Taiwan Main Orthopaedic Biotechnology Co., Ltd.

Surgical planning/navigation-enhancement system

• Primary Device ID: 04719878713078
• NIH Device Record Key: df553bbc-0db1-49ab-a873-e7fdc6d85024
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Headset
• Version Model Number: CDS-SSG-02
• Company DUNS: 658875222
• Company Name: Taiwan Main Orthopaedic Biotechnology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719878713078 [Primary]

FDA Product Code

• SBF: Orthopedic Augmented Reality

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-10
• Device Publish Date: 2024-12-02

Devices Manufactured by Taiwan Main Orthopaedic Biotechnology Co., Ltd.

• 04719878713016 - Disposable Passive Sphere: 2024-12-11
• 14719878713112 - Bone Drill: 2024-12-11
• 24719878713065 - Caduceus S: 2024-12-11
• 04719878713078 - Headset: 2024-12-10
• 04719878713078 - Headset: 2024-12-10
• 04719878713085 - Connection System: 2024-12-10
• 04719878713207 - Disposable Passive Sphere: 2024-12-10
• 04719878713337 - Router: 2024-12-10
• 04719878713511 - Navigation Cart: 2024-12-10